Hi:
I've read discussions in this forum regarding biological indicator classification, and it seems the jury is still out whether it's considered an accessory to the sterilizer device (which I understand is a Class IIb device). The argument for treating a BI as an accessory is the sterilizer manufacturer uses it to validate their sterilizer and thus the BI is included in their technical file. My question is, since most sterilizer manufacturer don't make their own BIs, does that mean the BI manufacturer can only market their product if the sterilizer manufacturer agrees to incorporate the BI in their technical file? Obviously this is not the case since BIs have always been marketed as standalone products. So my next question is, being an accessory according to the new MDR rules, does the BI manufacturer have to validate their BI with all compatible sterilizers so the latter can claim them as accessories?
What about the BI incubator/reader that has a software component? How should they be classified under MDR?
I've read discussions in this forum regarding biological indicator classification, and it seems the jury is still out whether it's considered an accessory to the sterilizer device (which I understand is a Class IIb device). The argument for treating a BI as an accessory is the sterilizer manufacturer uses it to validate their sterilizer and thus the BI is included in their technical file. My question is, since most sterilizer manufacturer don't make their own BIs, does that mean the BI manufacturer can only market their product if the sterilizer manufacturer agrees to incorporate the BI in their technical file? Obviously this is not the case since BIs have always been marketed as standalone products. So my next question is, being an accessory according to the new MDR rules, does the BI manufacturer have to validate their BI with all compatible sterilizers so the latter can claim them as accessories?
What about the BI incubator/reader that has a software component? How should they be classified under MDR?